Safeguarding American Agriculture

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October 18, 2007 

VETERINARY SERVICES MEMORANDUM NO. 800.58 

TO: VS Management Team 

 Directors, Center for Veterinary Biologics 

 Biologics Licensees, Permittees, and Applicants 

FROM: John R. Clifford /s/ John R. Clifford 

 Deputy Administrator 

SUBJECT: Sublicensing of Veterinary Biological Products 

I. PURPOSE 

This memorandum establishes guidance for the sublicensing of a veterinary biological 

product from one licensed veterinary biologics establishment to another biologics 

establishment. 

II. CANCELLATION 

This memorandum cancels Veterinary Services Memorandum No. 800.58, dated 

November 4, 1999. 

III. BACKGROUND 

Sublicensing occurs when a licensed establishment transfers the technology to produce a 

currently licensed product to another (receiving) establishment. The receiving 

establishment, in order to produce and market this product, must have or obtain an 

establishment license and obtain a product license according Title 9, Code of Federal 

Regulations, (9 CFR) Part 102. 

IV. PROCEDURES 

A. Licensing Requirements - The firm (applicant) seeking to produce and market a 

 product through sublicensing must submit the following items to the Center for 

 Veterinary Biologics-Policy, Evaluation, and Licensing (CVB-PEL). 

 1. Application for an Establishment License – An application for United States 

 Veterinary Biologics Establishment License (APHIS Form 2001) and supporting 

 materials according to 9 CFR 102.3. (Note: This does not apply if the firm 

 already has an establishment license.) 

United States 

Department of 

Agriculture

Animal and Plant 

Health Inspection 

Service 

Veterinary Services 

Washington, DC 

20250 
VETERINARY SERVICES MEMORANDUM NO. 800.58 

Page 2 

2. Application for Product License – An application for United States Veterinary 

Biological Product License (APHIS Form 2003). 

3. Permission to Use Previously Filed Data – Documented permission from the 

licensed firm transferring the technology for the applicant to support the current 

application using all requisite research, field trial, and production data submitted to 

CVB-PEL when the product was previously licensed. 

4. Request to Transfer Material – A request to CVB-PEL for approval to bring 

necessary production materials into the applicant’s production facility. 

5. Evidence of Technology Transfer – Documented evidence from the licensed 

firm that the applicant has been provided all the necessary technical information and 

assistance that is needed to produce the product in the same manner as it was produced 

by the licensed firm. 

6. New or Amended Facilities Documents – New or amended plot plan, 

blueprints, and legends of the applicant’s production facilities, as applicable, in 

accordance with 9 CFR 108. 

7. Outline of Production – An Outline of Production prepared in accordance with 

9 CFR 114.8 and 114.9. For vaccines, bacterins, antigens, and toxoids, see also 

Veterinary Services (VS) Memorandum 800.206 for guidance. All essential 

procedures must be identical to those of the licensed firm. 

8. Supporting Data – The CVB may request additional supporting data, generated 

by the license applicant, on a case-by-case basis. 

a. Tests for purity, identity, and virulence of Master Seeds and Master Cell 

Stocks. These tests will be required if new Master Seed or Master Cell Stocks are 

prepared by the license applicant, even though they are derived from the stocks 

provided by the licensed firm transferring the technology. Additional testing may 

be required on previously approved Master Seeds and Cell Stocks if the original 

testing does not meet all current testing requirements. 

 

b. An efficacy (immunogenicity) study. The license applicant may be 

required to conduct an efficacy study if the original efficacy study does not meet all 

current efficacy requirements; see VS Memorandum 800.202. Efficacy studies will 

be required of all applicants sublicensing a Rabies Vaccine. 

9. Test Reports – Veterinary Biologics Production and Test Reports (APHIS 

Forms 2008), prepared according to Veterinary Services Memorandum No. 800.53, 

for up to three consecutive satisfactory serials of the product. 

 
VETERINARY SERVICES MEMORANDUM NO. 800.58 

Page 3 

10. Labels – Labels prepared according to 9 CFR 112. All directions for use, 

warnings, or cautions from labels in use by the original licensee or any changes made 

by the applicant must be supported by valid data. 

B. Prelicense Testing - Before issuing a license, the CVB may conduct confirmatory 

 testing of Seeds, Cells, and production serials, as appropriate.